- Gilead Sciences, Inc. (Parsippany, NJ)
- …live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory Affairs , you will develop and execute Oncology ... regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise...Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within ... Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Global … more
- Bausch Health (Bridgewater, NJ)
- …writing CCDS and USPI documents for new products. + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements and ... skills and values drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- J&J Family of Companies (Raritan, NJ)
- …of America **Job Description:** Johnson and Johnson is currently seeking a **Medical Director , Global Medical Affairs , Biosurgery located** in **Raritan, ... with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs , Communications, Legal, Quality & Compliance, Preclinical, Health… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. Job Scope: The Director of Regulatory Affairs coordinates and oversees regulatory ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...regulatory experience + Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical ... or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- AbbVie (Florham Park, NJ)
- …with the scientific review, development, approval, execution, and communication of affiliate/area/ global medical affairs sponsored or supported clinical research ... will be based on qualifications listed below. Purpose: The Director provides specialist medical and scientific strategic and operational...area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs … more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Director , Clinical Development and Medical Affairs (Respiratory) Requisition JR000014860 Director , Clinical Development and Medical Affairs ... Location Bridgewater, NJ Additional Locations Job Description Summary Job Description The Director of Clinical Development and Medical Affairs ( Respiratory)… more
- AbbVie (Florham Park, NJ)
- … Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory , HEOR and other functional areas, provides leadership, oversight, and support ... title will be based on qualifications listed below. Purpose: The Senior Director provides specialist medical and scientific strategic and operational input into core… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... + Marketing/ commercial + GMP QA/ Supply chain / Regulatory Affairs **Leadership/** **team** **management:** + Createahighperformingteamenvironmentandacohesiveculturedrivenbyvaluesof… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …improve life by advancing the care of patients with life-threatening diseases. ** Director , Public Affairs , US HIV Prevention Communications & Media Relations** ... This role will work in partnership with the Sr Director in developing public relations strategies and tactics that... as well as coordinating with colleagues across Public Affairs ' global centers of expertise and … more
- System One (Florham Park, NJ)
- … Strategy Location: Florham Park, NJ (50% hybrid) Type: contract Overview Support the Regulatory Affairs (Executive Director ) in developing and executing ... to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies...timelines, and the quality of submissions + The Executive Director , Regulatory Affairs will review… more
- American Express (New York, NY)
- …this role?** Help propel your team and its business partners to success. Our Global Government Affairs office represents the company on important public policy ... issues around the world. Global Government Affairs colleagues work with departments...+ In collaboration with VP, State & Local Government Affairs , identify, assess and influence legislative and regulatory… more